Senior Principal Scientist, Translational Medicine

Denali Therapeutics; South San Francisco (CA); Sur place; USD 171 000 - 223 000; Plein temps

Avantages offerts par ce poste

401k plan

Healthcare coverage

ESPP

Broad range of benefits

Résumé du poste

Denali Therapeutics in South San Francisco seeks a PhD-level biomarker leader to drive cross-functional biomarker programs within Translational Medicine and oversee biomarker strategy for CNS-focused therapies.

You will design and implement assays, guide collaborations, prepare data for regulatory submissions, mentor scientists, and contribute to publications while advancing biomarkers for rare and neurodegenerative diseases.

Qualifications

• PhD in a relevant scientific discipline with 12+ years of industry/academic experience.
• Experience developing, executing, and interpreting complex biomarker assays in clinical studies.
• Experience contributing to regulatory submissions (BLA/NDA/IND) including biomarker sections.

Responsabilités

• Lead complex, cross-functional biomarker research programs within Translational Medicine.
• Define biomarker strategies to generate clinical evidence of target engagement and disease modulation.
• Direct design and implementation of biomarker assays in clinically relevant biosamples.
• Author biomarker strategy and data packages for regulatory submissions (BLAs, NDAs).
• Mentor and guide scientific work across lab and project teams.

Connaissances

Biomarker assays

Regulatory submissions

Data interpretation

Scientific communication

Team leadership

Formation

PhD in Biochemistry/Neurobiology/Molecular Biology/Pharmacology

Outils

Biomarker assay platforms

Description du poste

Denali Therapeutics Inc. is a biotechnology company pioneering a new class of biotherapeutics designed to cross the blood-brain barrier (BBB) using its proprietary TransportVehicle platform. With the first FDA-approved biologic specifically designed to cross the BBB, a clinically validated delivery platform and a growing portfolio of therapeutic candidates across all stages of development, we are advancing toward our goal of delivering effective medicines to transform the lives of people living with neurodegenerative diseases, lysosomal storage disorders and other serious diseases.We invite you to consider an opportunity with Denali to help achieve our goal of delivering meaningful therapeutics to patients.Partners with leaders across Discovery and Development to set biomarker strategy for large-molecule programs in rare, genetically defined, and neurodegenerative diseases. Shapes biomarker-driven clinical development plans that support dose selection, proof-of-concept, and deep patient phenotyping. Applies expert knowledge of drug development and regulatory science to move therapeutics through the clinic toward approval. Influences program direction and strengthens the organization’s scientific reputation in biomarker science.Key Accountabilities / Core Job ResponsibilitiesLead complex, cross-functional, and external biomarker research programs within Translational MedicineLead cross-functional teams that deliver therapeutic project team objectivesDefine biomarker strategies that generate clinical evidence of target engagement, pathway engagement, and disease-biomarker modulation, including surrogate or intermediate endpoints that support accelerated approvalDirect the design, qualification, and implementation of biomarker assays in clinically relevant biosamplesAuthor biomarker strategy and data packages for BLAs and other regulatory submissions, including briefing documents and health authority responsesInterpret complex data sets and communicate results to scientific, clinical, and leadership audiencesMentor and guide the scientific work of other scientists across lab and project teamsAdvance expertise in rare disease biomarkers, including lysosomal storage disorders, and integrate knowledge of adjacent disciplines such as CNS disordersContribute to patent filings, diligence reports, publications, and regulatory documentsRepresent the organization at scientific conferences and in academic partnershipsQualifications / SkillsRequiredTypically requires a PhD in a relevant scientific discipline (e.g., biochemistry, neurobiology, molecular biology, pharmacology) with 12+ years of industry and/or academic experienceExpertise in developing, executing, and interpreting complex biomarker assays in a clinical study settingExperience contributing to regulatory submissions (e.g., BLA, NDA, IND), including biomarker sections and health authority interactionsRecord of high-quality publications and/or presentations in rare disease, translational research, or biomarkersStrong written, oral, and presentation skills for scientific and cross-functional audiencesPreferredExperience in rare or orphan disease drug development, including lysosomal storage disorders, natural history studies, or patient registriesDirect experience supporting an accelerated approval submission or FDA/health authority meetings (e.g., Type B/C meetings)Salary Range: $171,000.00 to $223,000.00 . Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Denali offers a competitive total rewards package, which includes a 401k, healthcare coverage, ESPP and a broad range of other benefits. Learn more at https://www.denalitherapeutics.com/careersThis compensation and benefits information is based on Denali’s good faith estimate as of the date of publication and may be modified in the future.Denali is committed to its core company value of unity by creating a diverse and inclusive environment. We are proud to be an equal opportunity employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity and/or expression, status as a veteran, basis of disability, or any other federal, state, or local protected class.